FDA sends closeout letter to end Akzo API plant warning

The US FDA has posted a closeout letter to an AkzoNobel Mexican API plant seven months after it warned the facility.

Closeout of the US Food and Drug Administration (FDA) warning letter comes a year after inspectors visited the active pharmaceutical ingredient (API) plant on the outskirts of Mexico City. Failings found by inspectors led to a warning letter in November but AkzoNobel has now met the FDA standards.

Cesar Matto, compliance officer at the FDA, wrote: “Based on our evaluation, it appears that you have addressed the violation(s) contained in this warning letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.”

AkzoNobel was criticised for failing to investigate and review product deviations. API batches with black particles and a leak of hydraulic oil went uninvestigated and these shortcomings prompted the FDA to take action against AkzoNobel.

FDA inspectors also noted a lack of appropriate procedures for preventing the use of contaminated APIs. In May 2011 a contaminated lot of API was shipped to a US distribution centre. AkzoNobel realised the error and recalled the API but the FDA criticised its materials management system.

The FDA wrote: “Please provide detailed corrective actions showing that you have amended your materials management system to ensure that accurate classification of a material’s status is maintained throughout your custody, including during its transport between company units.”

In the third and final violation raised by the FDA warning letter inspectors criticise AkzoNobel for maintenance failings. From August 2010 to August 2011 there were at least ten requests related to oil leaks, the FDA wrote, and this indicated “an inadequate equipment maintenance programme.”

Having fixed these problems AkzoNobel has received a closeout letter from the FDA. The Agency told AkzoNobel it will “continue to monitor your state of compliance” but is satisfied the firm has fixed the violations.

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